Medicines Act 1968

130 Meaning of “medicinal product" and related expressions. U.K.

(1) Subject to the following provisions of this section, in this Act “medicinal product” means any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways, that is to say—

(a) use by being administered to one or more human beings or animals for a medicinal purpose;

(b) use, in circumstances to which this paragraph applies, as an ingredient in the preparation of a substance or article which is to be administered to one or more human beings or animals for a medicinal purpose.

(2) In this Act “a medicinal purpose” means any one or more of the following purposes, that is to say—

(a) treating or preventing disease;

(b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;

(c) contraception;

(d) inducing anaesthesia;

(e) otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing, or increasing or accelerating, the operation of that function or in any other way.

(3) In paragraph (b) of subsection (1) of this section the reference to use in circumstances to which that paragraph applies is a reference to any one or more of the following, that is to say—

(a) use in a pharmacy or in a hospital;

(b) use by a practitioner;

(c) use in the course of a business which consists of or includes the retail sale, or the supply in circumstances corresponding to retail sale, of herbal remedies.

[F1 (3A) An order made by the Agriculture Ministers may provide that, for the purposes of this Act, any specified description or class of medicated feeding stuff—

(a) is to be treated as a medicinal product (subject to the following provisions of this section), or

(b) is not to be so treated (notwithstanding anything in subsection (1) of this section).

(3B) In subsection (3A) of this section, “medicated feeding stuff” means any substance which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways, that is to say—

(a) use by being fed to one or more animals for a medicinal purpose or for purposes that include that purpose, or

(b) use as an ingredient in the preparation of a substance which is to be fed to one or more animals for a medicinal purpose or for purposes that include that purpose.

(3C) No order shall be made under subsection (3A) of this section unless a draft of the order has been laid before Parliament and approved by resolution of each House of Parliament.]

(4) Notwithstanding anything in subsection (1) [F2 or (3A)] of this section, in this Act “medicinal product” does not include any substance or article which is manufactured for use wholly or mainly by being administered to one or more human beings or animals, where it is to be administered to them—

(a) in the course of the business of the person who has manufactured it (in this subsection referred to as “the manufacturer”), or on behalf of the manufacturer in the course of the business of a laboratory or research establishment carried on by another person, and

(b) solely by way of a test for ascertaining what effects it has when so administered, and

(c) in circumstances where the manufacturer has no knowledge of any evidence that those effects are likely to be beneficial to those human beings, or beneficial to, or otherwise advantageous in relation to, those animals, as the case may be,

and which (having been so manufactured) is not sold, supplied or exported for use wholly or mainly in any way not fulfilling all the conditions specified in paragraphs (a) to (c) of this subsection.

(5) In this Act “medicinal product" shall also be taken not to include—

(a) substances used in dental surgery for filling dental cavities;

(b) bandages and other surgical dressings, except medicated dressings [F3 within subsection (5A) below];

(c) substances and articles of such other descriptions or classes as may be specified by an order made by the Ministers, the Health Ministers or the Agriculture Ministers for the purposes of this subsection.

[F4 (5A) Medicated dressings are within this subsection (and accordingly are not excluded from the definition of “medicinal product" by subsection (5)(b) above) if—

(a) their medication has a curative function which is not limited to sterilising the dressing; and

(b) they are not dressings of a kind to which the requirements of Article 2 of Council Directive 93/42/EEC F5 (placing medical devices on the market and putting them into service) apply or would apply but for Article 4 (devices intended for special purposes) or 22 (transitional provisions) of that Directive.]

(6) Where in accordance with the preceding provisions of this section a substance or article is a medicinal product immediately after it has been manufactured, imported or exported as mentioned in subsection (1) [F6 or (3B)] of this section, or immediately after the first occasion on which it has been sold or supplied as mentioned in [F7 the relevant] subsection, then . . . F8 it shall not cease to be a medicinal product for the purposes of this Act by reason only that, at any subsequent time, it is sold, supplied, imported or exported for use wholly or mainly in a way other than those specified in [F9 the relevant subsection].

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F10

(8) For the purposes of this Act medicinal products are of the same description if (but only if)—

(a) they are manufactured to the same specification, and

(b) they are, or are to be, sold, supplied, imported or exported in the same pharmaceutical form,

and in this Act “description”, in relation to medicinal products, shall be construed accordingly.

(9) In this Act “administer” means administer to a human being or an animal, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in this Act to administering [F11 (or feeding)] a substance or article is a reference to administering [F11 (or feeding)] it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle.

(10) For the purposes of this Act a document, advertisement or representation shall be taken to be likely to mislead as to the uses or effects of medicinal products of a particular description if it is likely to mislead as to any of the following matters, that is to say—

(a) any purposes for which medicinal products of that description can with reasonable safety be used;

(b) any purposes for which such products cannot be so used; and

(c) any effects which such products when used, or when used in any particular way referred to in the document, advertisement or representation, produce or are intended to produce.

Textual Amendments

F1 S. 130(3A)–(3C) inserted by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 13(2)

F2 Words inserted by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(7)

F3 Words in s. 130(5)(b) substituted (1.1.1995) by S.I. 1994/3119, reg. 2(a)

F4 S. 130(5A) inserted (1.1.1995) by S.I. 1994/ 3119, reg. 2(b)

F5 O.J. No. L 169 12.7.93 p.1.

F6 Words inserted by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(8)(a)

F7 Words substituted by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(8)(b)

F8 Words repealed by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(8)(c), Sch. 2

F9 Words substituted by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(8)(d)

F10 S. 130(7) repealed by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8) , s. 16 , Sch. 1 para. 3(9) , Sch. 2

F11 Words inserted by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(10)

Modifications etc. (not altering text)

C1 Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403 , art. 3(1)